Time-restricted eating in Alzheimer's disease: TREAD pilot trial design.

Background and objective: Time-restricted eating (TRE) may slow neurodegeneration and cognitive decline by stimulating metabolic processes that are neuroprotective. The primary aim of the TRE in Alzheimer's Disease (TREAD) pilot trial is to evaluate the feasibility of implementing a TRE intervention among individuals with mild cognitive impairment (MCI) and to obtain preliminary data on cognitive domains and blood biomarkers that are responsive to TRE. Methods: TREAD is an intervention trial for 30 adults aged 55-89 years with MCI. A pre/post design is used, with neuropsychological assessments, surveys, and blood biomarkers of cardiometabolic health and AD obtained before and after the intervention. The TRE intervention involves 16 h of continuous fasting and an 8 h eating window on 5 or more days per week for 12 weeks. Feasibility measures include participant enrollment, retention, adherence, acceptability of the intervention, and safety. Cognitive measures include executive function, working memory, processing speed, auditory attention, auditory verbal learning, visuospatial memory, category fluency, and phonemic fluency. Summary: TREAD is exploring an innovative approach to address cognitive decline and will provide critical preliminary data to inform and power a larger, longer-term, randomized controlled trial of TRE on cognitive trajectory among adults with cognitive impairment.